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NDC 11523-6655-01 Claritin 10 mg/1 Details

Claritin 10 mg/1

Claritin is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Bayer HealthCare LLC. The primary component is LORATADINE.

MedlinePlus Drug Summary

Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.

Related Packages: 11523-6655-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine

Product Information

NDC	11523-6655
Product ID	11523-6655_eaebed1d-2b0f-3fe7-e053-2a95a90a2d89
Associated GPIs	41550030000320
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Claritin
Proprietary Name Suffix	n/a
Non-Proprietary Name	Loratadine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	10
Active Ingredient Units	mg/1
Substance Name	LORATADINE
Labeler Name	Bayer HealthCare LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA019658
Listing Certified Through	2024-12-31

Package

Package Images

NDC 11523-6655-01 (11523665501)

Pricing Information	N/A
NDC Package Code	11523-6655-1
Billing NDC	11523665501
Package	1 BLISTER PACK in 1 POUCH (11523-6655-1) / 1 TABLET in 1 BLISTER PACK
Marketing Start Date	1993-04-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ac32d6f9-f553-4d5c-ad36-575af5ea56de Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Loratadine 10 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
itchy, watery eyes
sneezing
itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

adults and children 6 years and over: 1 tablet daily; not more than 1 tablet in 24 hours; children under 6 years of age: ask a doctor; consumers with liver or kidney disease: ask a doctor

Other information (Bottles)

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
store between 20° to 25°C (68° to 77°F)

Other information (Blister foil units)

safety sealed: do not use if the individual blister unit imprinted with Claritin (R) is open or torn
store between 20° to 25° C (68° to 77°F)
protect from excessive moisture

Inactive ingredients

corn starch, lactose monohydrate, magnesium stearate

Questions of comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton

Original Prescription

Strength

Non-Drowsy*

Claritin ®

loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel.

70 TABLETS

INGREDIENTS AND APPEARANCE

CLARITIN

loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-6655
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	458;Claritin;10
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11523-6655-1	1 in 1 POUCH	04/12/1993
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC:11523-6655-2	1 in 1 CARTON	04/12/1993
2		70 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:11523-6655-3	2 in 1 BLISTER PACK	04/12/1993
3		45 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:11523-6655-4	1 in 1 BLISTER PACK	04/12/1993
4		105 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:11523-6655-6	1 in 1 BLISTER PACK	04/12/1993
5		105 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:11523-6655-7	25 in 1 BOX	04/12/1993
6		1 in 1 POUCH; Type 0: Not a Combination Product
7	NDC:11523-6655-9	1 in 1 CARTON	04/12/1993
7		80 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:11523-6655-8	1 in 1 CARTON	04/12/1993
8		30 in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC:11523-6655-5	1 in 1 CARTON	04/12/1993
9		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019658	04/12/1993

Labeler - Bayer HealthCare LLC (112117283)

Revised: 10/2022

Document Id: eaebed1d-2b0f-3fe7-e053-2a95a90a2d89

Set id: ac32d6f9-f553-4d5c-ad36-575af5ea56de

Version: 8

Effective Time: 20221013